MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SS META SEMIEXTENDED DRILL GUIDE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71692803
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, a sureshot machine displays an error message, the ss meta semiextended drill guide probe was changed to a new probe.It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.
Event or Problem Description
It was reported that, a sureshot machine displayed an unspecified error message, the ss meta semiextended drill guide probe was changed to a new probe.It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible probable cause could include but not limited to software not programmed correctly, software not updated, connection or mechanical issues.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SS META SEMIEXTENDED DRILL GUIDE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12545922
• Report Number: 1020279-2021-07305
• Device Sequence Number: 20125939
• Product Code: OLO
• UDI-Device Identifier: 03596010648136
• UDI-Public: 03596010648136
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 71692803
• Device Catalogue Number: 71692803
• Device Lot Number: 20FK00006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/27/2021
• Patient Sequence Number: 1